On March 3, 2025 Daiichi Sankyo reported positive topline results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to ramucirumab and paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (Press release, Daiichi Sankyo, MAR 3, 2025, View Source [SID1234650858]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At a planned interim analysis, the Independent Data Monitoring Committee recommended unblinding the trial based on the superior efficacy of ENHERTU.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Gastric cancer is associated with a poor prognosis, particularly in advanced stages of the disease where the five-year survival rate is 5% to 10%.1,2 Following disease progression in the first-line metastatic setting of HER2 positive gastric cancer, there historically have been no HER2 directed medicines that have demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.3

ENHERTU is currently approved in more than 65 countries based on DESTINY-Gastric01, a randomized phase 2 trial, and DESTINY-Gastric02 and DESTINY-Gastric06, two single-arm phase 2 trials. DESTINY-Gastric04 is the first phase 3 trial of ENHERTU in HER2 positive advanced gastric cancer.

"ENHERTU is the first HER2 directed medicine to demonstrate an improvement in overall survival in a randomized phase 3 trial in the second-line metastatic setting of patients with HER2 positive gastric cancer, reinforcing previous findings seen in our other earlier phase gastric cancer trials," said Ken Takeshita, MD, Global Head, Oncology R&D, Daiichi Sankyo. "With these DESTINY-Gastric04 results, we will work with global regulatory authorities to seek approval in regions where ENHERTU is not currently indicated as a second-line option, as well as work to secure full approval in regions where ENHERTU is conditionally approved."

"We are committed to advancing the care of patients with metastatic gastric cancer and continuing to understand the role of ENHERTU in earlier lines of treatment," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "The results of DESTINY-Gastric04 show that second-line treatment with ENHERTU can extend survival compared with a chemotherapy-based regimen and should be considered for all eligible patients with HER2 positive metastatic gastric cancer."

The safety profile seen in DESTINY-Gastric04 is consistent with the established safety profile of ENHERTU.

Data from DESTINY-Gastric04 will be presented at an upcoming medical meeting and shared with global regulatory authorities.

About DESTINY-Gastric04
DESTINY-Gastric04 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen.

The primary endpoint is OS. Secondary endpoints include investigator-assessed progression-free survival, objective response rate, duration of response, disease control rate and safety.

DESTINY-Gastric04 enrolled 494 patients in Asia, Europe and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Gastric Cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth leading cause of cancer-related death.1,2 Approximately one million cases of gastric cancer were diagnosed in 2022.2 Gastric cancer is associated with a poor prognosis, particularly in advanced stages of the disease where the five-year survival rate is 5% to 10%.1,2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including gastric cancer.4 Approximately one in five gastric cancers are considered HER2 positive.4,5

Following disease progression in the first-line metastatic setting of HER2 positive gastric cancer, there historically have been no HER2 directed medicines that have demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.3

About ENHERTU
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in the U.S. for the treatment of adult patients with unresectable or metastatic HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 50 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in Brazil, Israel, Russia and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program
A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

On March 3, 2025 Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported Dr. Pam Garzone, Chief Development Officer of Anixa, will be attending the Alliance for Cancer Gene Therapy (ACGT) Summit 2025 and participating as a panelist on the Gynecologic and Breast Cancers panel (Press release, Anixa Biosciences, MAR 3, 2025, View Source [SID1234650823]). The Alliance for Cancer Gene Therapy Summit 2025 is being held on Wednesday and Thursday, March 19 – 20, 2025, at the Alexandria Center for Life Science in New York City.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Garzone will join leading experts in the field to discuss advancements in cell and gene therapy, including Anixa’s CAR-T therapy for ovarian cancer, and its potential impact on gynecologic and breast cancers. The panel is scheduled for Wednesday, March 19, 2025, from 11:15 AM – 12:15 PM ET.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "We are pleased that Anixa and Dr. Garzone were invited to share insights at the ACGT Summit. Our discussions and contributions to the development of novel cancer therapies will help drive meaningful discussions on the future of gene-based treatments for gynecologic and breast cancers."

The Alliance for Cancer Gene Therapy Summit 2025 will bring together leading physician scientists advancing research to develop curative cell and gene therapies for solid tumor cancers.

For more information about the conference, visit Alliance for Gene Therapy Summit 2025.

On March 3, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that management will present at the TD Cowen 45th Annual Health Care Conference taking place March 3-5, 2025 in Boston, MA (Press release, Sutro Biopharma, MAR 3, 2025, View Source;utm_medium=rss&utm_campaign=sutro-biopharma-to-present-at-the-td-cowen-45th-annual-health-care-conference [SID1234650841]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.

On March 3, 2025 Silexion reported the completion of its initial study evaluating SIL-204 in orthotopic pancreatic cancer models, a critical milestone that could continue to position its next-generation RNAi therapy at the forefront of KRAS-driven cancer treatment (Press release, Silexion Therapeutics, MAR 3, 2025, View Source [SID1234650859]). With data analysis now underway and initial results expected in the coming weeks, according to the company’s latest announcement, anticipation seems high for what could be a pivotal breakthrough, if indeed the data is positive.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A Potential Step Toward Transforming Pancreatic Cancer Treatment

Silexion’s latest study could mark an important advancement in validating systemic administration of SIL-204. The study specifically assessed the therapy’s ability to reduce primary tumor growth and inhibit metastatic spread in clinically relevant orthotopic pancreatic cancer models—providing a more accurate representation of human disease progression than traditional subcutaneous xenograft models.

Silexion’s work with SIL-204 has already demonstrated compelling preclinical efficacy, including a 50% reduction in tumor growth and complete necrosis in half of treated tumors in previous systemic administration studies. Moreover, SIL-204 has shown sustained therapeutic levels for over 56 days from a single dose—an unprecedented achievement in RNAi-based therapies for KRAS-driven cancers.

Why This Matters: A Potential First for Metastatic Pancreatic Cancer

KRAS-driven cancers remain among the most aggressive and difficult-to-treat malignancies, particularly in pancreatic cancer, where over 90% of tumors harbor KRAS mutations. While other companies have attempted to target KRAS with small molecule inhibitors, Silexion’s RNAi-based approach aims to silence multiple key KRAS mutations, including G12D, G12V, G12R, Q61H, and G13D—offering a broader and potentially more effective therapeutic strategy.

The ability to target both primary and metastatic pancreatic cancer via systemic administration would represent a major breakthrough, as Silexion has not previously demonstrated this effect in metastatic models. If the orthotopic model results show significant impact on metastases, this could mark a critical validation step, potentially differentiating SIL-204 from existing KRAS-targeting approaches and opening the door to expanded clinical applications.

The industry seems to be closely watching Silexion’s progress in light of the recent wave of multi-billion-dollar acquisitions in precision oncology. With major players like Pfizer acquiring Seagen for $43 billion and AbbVie purchasing Immunogen for $10.1 billion, the demand for novel cancer therapies seems to have increased in recent years. According to news reports, Maxim Group recently reaffirmed its strong buy rating on SLXN with a $9 price target, citing the company’s strong clinical trajectory and the ongoing validation of its RNAi platform.

Upcoming Data Readout: A Potential Critical Catalyst

Silexion’s announcement that initial results from the orthotopic model study will be released in March 2025 has sparked significant interest. If the data is positive, it could provide further confirmation of SIL-204’s ability to target both primary and metastatic pancreatic cancer, marking the first time the company demonstrates systemic efficacy against metastatic disease.

If the upcoming results align with previous systemic administration findings and show significant impact on metastases, SIL-204 could emerge as a leading next-generation RNAi therapy for KRAS-driven cancers—potentially, in the future, reshaping the treatment paradigm for one of the deadliest malignancies.

Silexion Therapeutics has continued to execute on its strategy, pushing the boundaries of RNAi therapeutics for one of the most aggressive cancers. With data from the orthotopic pancreatic cancer study expected in March, many will likely be watching closely. If the upcoming results are positive and demonstrate impact on metastases, they could serve as a major catalyst for the company, potentially redefining its role in the precision oncology landscape.

Given the strong track record of preclinical success, increasing interest, and a competitive landscape ripe for M&A activity, Silexion Therapeutics is undoubtedly a company to watch in 2025.

On March 3, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the year ended December 31, 2024, and highlighted recent Company progress (Press release, ArriVent Biopharma, MAR 3, 2025, View Source [SID1234650824]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This has been a productive year for ArriVent that included strong achievement across our firmonertinib clinical programs and significant execution of our company strategy through the expansion of our ADC portfolio. The differentiated potential of firmonertinib to address classical and uncommon EGFR mutations was reinforced by the robust anti-tumor activity in NSCLC patients with EGFR PACC mutations reported at the World Conference on Lung Cancer, and the preclinical data presented at AACR (Free AACR Whitepaper)" said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "We also bolstered our ADC portfolio with the recent in-licensing of ARR-217 (MRG007) and research collaboration with Alphamab, underscoring our commitment to further expand our pipeline and develop new innovative therapies to potentially treat cancer patients with unmet medical need."

Dr. Yao continued, "We have achieved our target enrollment of 375 patients in our global, pivotal Phase 3 monotherapy study of firmonertinib in first-line NSCLC patients with EGFR exon 20 insertion mutations. In addition, we plan to provide an update on our plans to investigate firmonertinib as monotherapy in first line NSCLC patients with EGFR PACC mutations in the first half of 2025. For our ADC portfolio, we selected our next-generation ADC candidate, ARR-002, for IND-enabling activities. Our focus continues to be on executing across our near-term catalysts and we are poised for an impactful year ahead."

Recent and Full Year 2024 Highlights

Firmonertinib

● Achieved target enrollment for the global pivotal Phase 3 monotherapy study of firmonertinib in first-line NSCLC EGFR exon20 insertion mutations (FURVENT; NCT05607550). Earlier this year, ArriVent reached its target enrollment in the FURVENT study. Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor, received FDA Breakthrough Therapy Designation in this patient population.
● Positive proof-of-concept data in EGFR PACC mutant NSCLC. In September 2024, ArriVent presented interim Phase 1b clinical data for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations (FURTHER; NCT05364043) during the Presidential Symposium at the

2024 World Conference on Lung Cancer and hosted a virtual webinar. Firmonertinib demonstrated robust systemic and CNS anti-tumor activity with a manageable safety profile consistent with previous trials in what we believe to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined population of EGFR PACC mutant NSCLC.
● Presentation of preclinical data for firmonertinib at the 2024 AACR (Free AACR Whitepaper) Annual Meeting. In April 2024, ArriVent presented data evaluating firmonertinib in preclinical models with EGFR exon 20 insertion mutations and with P-loop and alpha-c helix compressing (PACC) mutations at the AACR (Free AACR Whitepaper) Annual Meeting. In the preclinical study, firmonertinib was observed to be broadly active across a wide range of uncommon mutations including PACC and exon 20 insertion mutations.
● Initiated Phase 1b combination study with firmonertinib and SHP2 allosteric inhibitor ICP-189. In March 2024, ArriVent’s clinical collaboration partner Beijing InnoCare Pharma Tech Co., Ltd., dosed the first patient in the Phase 1b combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations.
Pipeline

● Added ARR-217 (MRG007) to our pipeline from Lepu Biopharma. In January 2025, ArriVent entered into a collaboration with Lepu Biopharma Co., Ltd. for ARR-217, an ADC with the potential to target several GI cancers. Under the agreement, ArriVent obtained the exclusive rights to develop and commercialize ARR-217 worldwide outside of greater China, which includes mainland China, Hong Kong, Macau and Taiwan.
● Selected a next-generation antibody drug conjugate (ADC) candidate. In late 2024, ArriVent and its partner, Aarvik Therapeutics, Inc., selected a multi-target multivalent ADC candidate, ARR-002, for the treatment of solid tumors. ArriVent has initiated IND-enabling studies for ARR-002.
● Entered into an ADC collaboration agreement with Alphamab. In June 2024, ArriVent entered into a collaboration agreement with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (Alphamab), a wholly owned subsidiary of Alphamab Oncology, to discover, develop and commercialize novel ADCs for the treatment of cancers. Under the agreement, both companies leverage Alphamab’s proprietary linker-payload platform and glycan-conjugation technology to identify novel ADCs for oncology indications. The collaboration agreement grants ArriVent exclusive rights to develop and commercialize ADCs globally, except greater China, which includes mainland China, Hong Kong, Macau and Taiwan.
Upcoming Milestones

● EGFR PACC plans. Data from the FURTHER Phase 1b (NCT05364043) trial continues to mature for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations. ArriVent expects to provide an update on our plans to develop firmonertinib in EGFR PACC mutant NSCLC in the first half of 2025.

● First IND Filing for ADC Program. ArriVent and its partner, Lepu BioPharma, plan to file the first IND for ARR-217 in the first half of 2025.

● Top-line pivotal Phase 3 data. Firmonertinib has reached its target enrollment in the FURVENT study. ArriVent anticipates having top-line data in 2025 and expects to provide an update on timing of the top-line Phase 3 data release in Q2 2025.
2024 Financial Results

● As of December 31, 2024, the Company had cash, cash equivalents, and short and long-term investments of $266.5 million, which is expected to fund operations into 2026. Net cash used in operations was $70.2 million and $55.8 million for the years ended December 31, 2024 and 2023, respectively. During 2024, ArriVent completed an IPO raising net proceeds of $183.2 million, after deducting underwriting discounts, commissions, and other offering expenses.

● Research and development expenses were $79.0 million and $64.9 million for the years ended December 31, 2024 and 2023, respectively. The increase in expense was primarily due to increased headcount and clinical expense related to firmonertinib.

● General and administrative expenses were $15.3 million and $9.7 million for the years ended December 31, 2024 and 2023, respectively. The increase in expense was primarily due to expenses related to expanding the infrastructure necessary for operating as a public company.

● Net loss was $80.5 million and $69.3 million for the years ended December 31, 2024 and 2023, respectively.